Trial intelligence / Profile preview

Rifaximin Prophylaxis for Travellers' Diarrhoea in South/Southeast Asia

NCT00979056Phase 3

Key facts

Status: Completed
Start: Oct 2009
Primary completion: Mar 2012
Countries: 1
Modality: Small Molecules

Drugs: rifaximin
Conditions: traveler's diarrhea (TD)

Overview

Phase 3, randomised, double-blind trial in traveler's diarrhea (TD) comparing Rifaximin with Placebo (2 arms). Primary endpoint: Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Started Oct 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Rifaximin
Rifaximin 400 mg/day
Placebo
Lactose placebo

Endpoints

Primary

Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stoolFrom first day of travel to 1 week after return

Secondary

Documentation of adverse effects and tolerance of prophylaxis with rifaximinFrom first day of travel to 1 week after return
Evaluation of prevention of post infectious irritable bowel syndrome6 months after return

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